Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section

IUD Insertion Complication Clinical Trial

Official title:

Effect of Adding Vaginal Isosorbide Mononitrate to Misoprostol Prior to Intrauterine Device Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03587077
• Other study ID #: Pain during IUD insertion
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: May 2019

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: Eman I. Ramadan, BSc
• Phone: 00201063959596
• Email: emanelmelwany[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.

Description:

Fear of pain during insertion of an IUD may deter women from choosing the IUD as a method of contraception. According to Hubacher et al. predictors of increased pain during IUD insertion include nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding. Allen et al. predicted pain to be greater based on history of no previous vaginal delivery, and difficulty of the procedure. Pharmacological interventions for pain control during IUD insertion include analgesics, local anesthetics, and the use of prostaglandins to soften the cervix; however, there is wide variation in the use of these methods . Misoprostol has also been proposed as an agent to ease IUD insertion and decrease procedure-associated pain .

Nitrous oxide has been used for years for procedural analgesia in outpatient settings and has recently been investigated as an approach to pain management in the context of IUD insertion .

Sewell and Vincent have been offering nitrous oxide for reducing the pain of IUD insertion and have had a positive response.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 113
• Est. completion date: May 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:We will include

• Nonpregnant women,

• aged 18-45 years, .delivered before only by elective CS and did not receive any analgesics in the 24 h prior to IUD insertion.

Exclusion Criteria:We will exclude

• Women with any uterine abnormalities as congenital anomalies,

• Women with endometrial lesions,

• Women with adenomyosis,

• Women with fibroids,

• Women with intrauterine adhesions,

• Women with chronic pelvic pain,

• Women with spasmodic dysmenorrhea,

• Women with abnormal uterine bleeding,

• Women with history of cervical surgery, .Women with allergy to misoprostol or isosorbide mononitrate or any medical disease that contraindicates its use and those who refused to participate in the study.

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

Drug:
• Misoprostol
vaginal application
• Placebos
vaginal application
• isosorbide mononitrate
vaginal application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (22)

Akintomide H, Sewell RD, Stephenson JM. The use of local anaesthesia for intrauterine device insertion by health professionals in the UK. J Fam Plann Reprod Health Care. 2013 Oct;39(4):276-80. doi: 10.1136/jfprhc-2012-100486. Epub 2013 Feb 5. — View Citation

Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD007373. — View Citation

Allen RH, Carey MS, Raker C, Goyal V, Matteson K. A prospective cohort study of pain with intrauterine device insertion among women with and without vaginal deliveries. J Obstet Gynaecol. 2014 Apr;34(3):263-7. doi: 10.3109/01443615.2013.868424. Epub 2014 Jan 31. — View Citation

Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1. — View Citation

Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. — View Citation

Bahamondes L, Mansour D, Fiala C, Kaunitz AM, Gemzell-Danielsson K. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care. 2014 Jan;40(1):54-60. doi: 10.1136/jfprhc-2013-100636. Epub 2013 Sep 27. Review. — View Citation

Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65. — View Citation

Carusi, D. A., & Goldberg, A. B. (2015). Intrauterine contraceptive device: insertion and removal. In: M. Zieman (Ed), UpToDate. Retrieved from http://www.uptodate.com/home .

d'Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 2007 Jun;75(6 Suppl):S2-7. Epub 2007 Apr 19. Review. — View Citation

Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC). U.S. Selected Practice Recommendations for Contraceptive Use, 2013: adapted from the World Health Organization selected practice recommendations for contraceptive use, 2nd edition. MMWR Recomm Rep. 2013 Jun 21;62(RR-05):1-60. — View Citation

Edmunds, M. W., & Mayhew, M. S. (2014). Pharmacology for the primary care provider (4th ed.). St. Louis, MI: Elsevier Mosby.

Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13. — View Citation

Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11. — View Citation

Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1. — View Citation

Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. — View Citation

Kass-Wolff JH, Fisher JE. Evidence-based pain management for endometrial biopsies and IUD insertions. Nurse Pract. 2014 Mar 13;39(3):43-50. doi: 10.1097/01.NPR.0000434094.19101.d1. Review. — View Citation

Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;(7):CD007373. doi: 10.1002/14651858.CD007373.pub3. Review. — View Citation

Maguire K, Morrell K, Westhoff C, Davis A. Accuracy of providers' assessment of pain during intrauterine device insertion. Contraception. 2014 Jan;89(1):22-4. doi: 10.1016/j.contraception.2013.09.008. Epub 2013 Sep 21. — View Citation

Singh RH, Thaxton L, Carr S, Leeman L, Schneider E, Espey E. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016 Nov;135(2):145-148. doi: 10.1016/j.ijgo.2016.04.014. Epub 2016 Jul 16. — View Citation

Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, Secura GM. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012 May 24;366(21):1998-2007. doi: 10.1056/NEJMoa1110855. — View Citation

World Health Organization. Medical eligibility criteria for contraceptive use. Geneva (Switzerland): WHO; 2010.

Zhuo Z, Yu H, Jiang X. A systematic review and meta-analysis of randomized controlled trials on the effectiveness of cervical ripening with misoprostol administration before hysteroscopy. Int J Gynaecol Obstet. 2016 Mar;132(3):272-7. doi: 10.1016/j.ijgo.2015.07.039. Epub 2015 Dec 11. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of successful IUD insertion	Defined by a distance from the IUD to the endometrial end of less than 25 mm	10 minutes

External Links

•   Guttmacher Institute. (2015). Contraceptive use in the United States
•   SFP guideline 89: 75-84